(346 days)
The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities.
The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.
The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital.
Symani is composed of three main components (Figure 1):
- The Console, which is a reusable equipment and not sterile; .
- The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and
- . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide
Here's a detailed breakdown of the acceptance criteria and the study that proves the Symani Surgical System meets them, based on the provided text:
Overview of Device and Intended Use:
The Symani Surgical System is an electromechanical system for open microsurgery, specifically intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts (between 0.1 and 2.5 mm). Its primary indications are in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities for adults. It's designed to provide motion scaling and tremor reduction, assisting trained physicians in an appropriate operating environment.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Symani Surgical System are primarily derived from the "Special Controls" section and the "Performance Testing - Bench" table (Table 5). The reported device performance is indicated as "PASS" for all listed bench tests.
| Acceptance Criteria Category | Specific Criterion (from "Special Controls" or "Performance Testing - Bench") | Reported Device Performance (Table 5) |
|---|---|---|
| Bench/Performance Testing | ||
| Accuracy (Translational & Orientational) | (b)(4)* for each translational axis, Roll accuracy (b)(4), Pitch and Yaw accuracy (b)(4) | PASS |
| System Resolution | XXY axes (b)(4), RPY axes (b)(4) | PASS |
| Latency | (b)(4)* | PASS |
| Repeatability | (b)(4)* | PASS |
| Scaling Testing | (b)(4)* scaling down factors with a (b)(4)* tolerance range | PASS |
| Hold Testing | (b)(4)* | PASS |
| Workspace Testing (Translational) | Each axis shall report a workspace value between (b)(4)* | PASS |
| Workspace Testing (Angular) | (b)(4)* | PASS |
| System Use-Life | No structural failure or malfunctions shall be observed. No component shall be repaired or replaced. | PASS |
| Drop Testing (Master Controller) | No impact on performances by Master Controller drops. | PASS |
| Emergency Stop Testing | Motors stops at (b)(4)* | PASS |
| Cutting Performance | The Needle Holder Suture Cut instrument shall allow to perform at least (b)(4)* consecutive micro suture cuts. | PASS |
| Stitching Performance (Dilator) | The Dilator instrument shall allow to perform at least (b) consecutive stitches with microsutures. | PASS |
| Stitching Performance (Needle Holder) | The Needle Holder and Needle Suture Cut Instruments shall allow to perform at least (b)(4)* consecutive stitches with microsutures. | PASS |
| Grip Force (Micro/Supermicro NH) | The Micro and Supermicro Needle Holder Instrument shall perform a minimum gripping force of (b)*. | PASS |
| Grip Force (NH with Cutter) | The Needle Holder with Cutter Instrument shall have gripping force reduced of max (b)(4)* compared with Needle Holder Instrument. | PASS |
| Grip and Cutting Reliability | Reliability of 95% and confidence level of 85% with grip force (b)(4)* | PASS |
| Needle Compatibility (Micro NH) | Micro Needle Holder shall firmly grasp needles with diameters between 150-70 μm. | PASS |
| Needle Compatibility (Supermicro NH) | Supermicro Needle Holder shall firmly grasp needles with diameters below 100 μm. | PASS |
| Knot Tying (Micro NH/NHSC) | The Micro Needle Holder and Micro Needle Holder Suture Cut shall allow to tie knots with microsurgical suture in the range of 8-0 and 10-0. | PASS |
| Knot Tying (Supermicro NH/NHSC) | The Supermicro Needle Holder and Supermicro Needle Holder Suture Cut shall allow to tie knots with microsurgical suture in the range of 10-0 and 12-0. | PASS |
| Knot Tying (Micro Dilator) | The Micro Dilator instrument shall allow to tie knots with microsurgical suture in the range of 8-0 and 10-0. | PASS |
| Knot Tying (Supermicro Dilator) | The Supermicro Dilator instrument shall allow to tie knots with microsurgical suture in the range of 10/0 and 12/0. | PASS |
| Structural Integrity (Shaft Bending) | The Instruments shaft shall not break. | PASS |
| Structural Integrity (Shaft Co-manipulation/Collision) | The Instruments shaft shall not break. | PASS |
| Structural Integrity (Needle Holder Repetitive Gripping) | The Needle Holder shall withstand repetitive gripping actions without functional (grip force (b)(4)*) or structural failures. | PASS |
| Structural Integrity (Instruments Jaws Resistance) | Instruments tips shall withstand worst-case load conditions without breaking. | PASS |
| Microscope Compatibility (Head and Arm Fit) | The microscope's head and arm shall fit between Micromanipulators avoiding collision with the Micromanipulators and Instruments. | PASS |
| Microscope Compatibility (Working Distance) | The working distance range shall be adequate to have an appropriate vision of the surgical site, whilst avoiding any collision with Symani Instruments and Micromanipulators. | PASS |
| Microscope Compatibility (Setup/Vision) | The user shall be able to setup the Symani and the Vision System to reach the area to be treated independently to the body districts. Each user involved in the surgery shall have a clear vision of the operating field image. The user shall be able to manage the microscope while seated at the surgical console. | PASS |
| Clinical Performance (Effectiveness) | ||
| Intraoperative patency (Free-Flap) | Extremities: 90.9% (95% CI: [78.3%, 97.5%]) | Achieved (90.9% - 100%) |
| Breast: 100% (95% CI: [85.8%, 100.0%]) | ||
| Intraoperative patency (Lymphatic) | Upper Extremity: 96.7% (95% CI: [88.5%, 99.6%]) | Achieved (94.3% - 96.7%) |
| Lower Extremity: 94.3% (95% CI: [86.0%, 98.4%]) | ||
| Rate of intra-operative approach changes from robotic to manual | Upper/lower limbs (Free-Flap): 11.1% (4/36) | Achieved (7.7% - 11.1%) |
| Breast (Free-Flap): 7.7% (1/13) | ||
| Upper Extremity (Lymphatic): 6.7% (4/60) | ||
| Lower Extremity (Lymphatic): 5.6% (4/71) | ||
| Clinical Performance (Safety) | ||
| Freedom from device related serious adverse events prior to discharge | Extremities (Free-Flap): 0% (0/31) | Achieved (0%) |
| Breast (Free-Flap): 0% (0/24) | ||
| Upper Extremities (Lymphatic): 0% (0/33) | ||
| Lower Extremities (Lymphatic): 0% (0/37) | ||
| 3-day anastomosis specific reoperation rate | Extremities (Free-Flap): 3.23% (95% CI: [0.1%, 16.7%]) - Lower than literature [3] | Achieved (0% - 3.23%) |
| Breast (Free-Flap): 0% (95% CI: [0.00%, 14.8%]) | ||
| Lymphatic (30-day reoperation rate): 0.00% (95% CI: [0.00%,0.00%]) |
*Note: "(b)(4)" indicates redacted proprietary information, implying the specific numerical criteria were defined and met but are not publicly disclosed in this document.
2. Sample Sizes and Data Provenance
The primary clinical evidence for this device comes from a multicenter clinical study and a cadaver/simulated use study.
-
Clinical Study:
- Sample Size:
- Free-Flap Procedures: 93 evaluable patients.
- Lymphatic Surgery: 70 evaluable patients.
- Total: 163 evaluable patients.
- Data Provenance: The Symani study is an OUS (Outside US), prospective, single-arm, multicenter, post-market clinical follow-up (PMCF) study. It also allowed for retrospective data collection. This indicates data from European centers ("6 European centers" mentioned in Commercial Data and Literature section). Therefore, the data provenance is European (OUS) and a mix of retrospective and prospective collection.
- Sample Size:
-
Cadaver Testing: Not specified in terms of sample size for cadavers, but "several standard procedures" were simulated.
-
Simulated Use Testing: 20 experienced surgeons (>5 years of microsurgery practice) and 16 users with no microsurgery experience participated.
3. Number of Experts and Qualifications for Ground Truth
- Cadaver Testing: "a team composed of two expert surgeons and six residents" participated. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert surgeons."
- Simulated Use Testing: "20 experienced surgeons (>5 years of microsurgery practice)" and "16 users with no microsurgery experience." Their input was used to assess precision in stitch placement by measuring distances and angles. This serves as a form of ground truth for performance comparison.
- Clinical Studies: The "ground truth" for clinical effectiveness and safety endpoints (e.g., anastomosis patency, adverse events, reoperation rates) was based on direct observation and clinical assessment by the participating trained physicians (surgeons) and potentially study staff at the multicenter sites. The study design does not specify adjudication by independent experts for these clinical outcomes, but rather the direct clinical results.
4. Adjudication Method for the Test Set
- Clinical Study (Test Set/Clinical Data): The document does not explicitly describe an independent adjudication method (e.g., 2+1, 3+1 consensus) for the clinical outcomes in the human clinical study. The intraoperative patency and adverse events are reported as direct outcomes from the clinical settings. Anastomosis revisions, for example, were performed by the operating surgeon if patency was not achieved on the first attempt.
- Simulated Use Testing: Data analysis of needle passage parameters (distance and angle) was conducted through a paired T-test. The measurements were taken through a digital microscope, implying a quantitative, objective assessment rather than subjective expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was reported. The device is a surgical system, not an AI-assisted diagnostic or imaging interpretation tool.
However, a simulated use study did compare the precision of stitch placement with the system (robotic) versus manual instruments.
- Comparison: Use of Symani vs. manual execution.
- Effect Size/Performance Improvement:
- Precision (stitch placement): Use of Symani was associated with greater precision (smaller difference between right and left distances from the cut on latex tissue) compared to manual execution.
- Experienced microsurgeons: p = 0.02 (statistically significant improvement).
- Users with no microsurgery experience: p = 0.36 (no statistically significant difference, but trend suggests improvement).
- Angular Precision: Higher precision using Symani for angular precision (entry/exit angles relative to the vertical cut).
- Users with no microsurgery experience: p
- Precision (stitch placement): Use of Symani was associated with greater precision (smaller difference between right and left distances from the cut on latex tissue) compared to manual execution.
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